Spinal Stenosis LumbarNCT04443738
Long Term Follow up of Spinal Stenosis Inpatients Treated With Korean Integrative Medicine Treatment.
An observational study of Spinal Stenosis Lumbar and Medicine, Korean Traditional, run by Jaseng Medical Foundation at 1 site in South Korea.
Trial summary
The purpose of this study is to reveal the effectiveness and safety of integrative Korean medicine for spinal stenosis by observation inpatients treated with integrative Korean medicine. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Spinal Stenosis Lumbar, Medicine, Korean Traditional
- What is being tested?
- phone survey
- How many people
- 378 participants
- Where
- 1 siteSouth Korea
- Study dates
- 12 Jun 2020to 16 Sep 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The subjects for study are patients diagnosed with spinal stenosis and who have been admitted to four Jaseng Hospital of Korean medicine (Gangnam, Bucheon, Daejeon, and Haeundae) for 2015.01-2018.12.
Who may be able to join
- Patients diagnosed with spinal stenosis by an Korean medicine doctor and was admitted to Jaseng hospital of Korean medicien.
- Patients undergone MRI readings of central spinal stenosis
- Patients have no communication problems
- Patients have agreed to participate the study.
Who cannot join
- Patients who have been diagnosed with certain serious diseases that may cause back pain or neck pain (tumor metastases to the spine, acute fractures, spinal dislocations, and so on)
- Patient hospitalized for pain caused by a traffic accident
- Patients with serious mental illness
- Patients deemed unable to participate in the clinical research by other researchers
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to reveal the effectiveness and safety of integrative Korean medicine for spinal stenosis by observation inpatients treated with integrative Korean medicine.
Read the detailed description
This study is a prospective observational study. The subjects for study are patients diagnosed with spinal stenosis and who have been admitted to four Jaseng Hospital of Korean medicine (Gangnam, Bucheon, Daejeon, and Haeundae) for 2015.01-2018.12.
Medical records of selected patients will be analyzed, and telephone surveys will be conducted for each patient. The survey questions are Numeric rating scale (NRS), Oswestry disability index (ODI), quality of life, and Patient Global Impression of Change (PGIC), etc.
- Being tested
- phone survey
- Keywords
- acupuncture therapy, herbal medicine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
phone surveyOther
A questionnaire about the current symptoms and satisfaction for recieved treatment will be conducted over the phone for patients.
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric rating scale (NRS)
NRS uses an 11-point scale to evaluate current neck pain and radiating pain where no pain is indicated by '0', and the worst pain imaginable by '10'. NRS was assessed at admission, 2 weeks after admission, discharge, and long term follow up.
Measured: Finish survey by August 2020
Secondary outcomes (7)
Oswestry disability index (ODI)
he ODI is a 10-item questionnaire developed to evaluate the degree of disability for low back pain. Each item is divided into 6 levels, and 0 to 5 points are awarded. The higher the score, the greater the degree of disability. We will conduct an validated Korean ODI questionnaire
Measured: Finish survey by August 2020
The five level version of EuroQol-5 Dimension (EQ-5D)
EQ-5D is most widely used as a method of indirectly calculating the quality of life from various aspects. The EQ-5D-5L consists of 5 questions (mobility, self-care, usual activities, pain, anxiety/depression) that ask about the current state of health, and answers each question with 5 likert. (1=I have no problems about, 2=I have slight problems about, 3=I have moderate problems about, 4=I have severe problems about, 5=I am unable to about) In this study, the validated Korean version questionnaire will be used
Measured: Finish survey by August 2020
Patient Global Impression of Change (PGIC)
PGIC is an indicator that evaluates the improvement of patients in 7 steps, and the subject responds with improvement of functional limitation after treatment with 7 likert. (1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, 7=very much worse).
Measured: Finish survey by August 2020
Spine surgery
The number of spinal surgery after discharge
Measured: Finish survey by August 2020
Current symptoms
Possible walking time without pain, neurological claudication
Measured: Finish survey by August 2020
Treatment after discharge
Treatment history in the last month
Measured: Finish survey by August 2020
hanbangchilyo manjogdo 9/5000 Satisfaction with integrative Korean medicine
Preference for integrative Korean medicine, satisfaction with integrative Korean medicine, How helpful hospitalization has been for returning to work and adjusting to daily life.
Measured: Finish survey by August 2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2020
- Study start12 Jun 2020
- Primary completion16 Sep 2020
- Study completion16 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for Spinal Stenosis LumbarStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 378 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jaseng Medical Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, In-Hyuk Ha, KMD, Jaseng Medical Foundation
- Investigators
- In-Hyuk Ha, Dr., Study director, Jaseng Medical Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04443738
- Sponsor's protocol ID
- JS-CT-2020-06
- Status last verified
- Jul 2022
- First submitted
- 19 Jun 2020
- Last updated
- 26 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Weinstein JN, Tosteson TD, Lurie JD, Tosteson AN, Blood E, Hanscom B, Herkowitz H, Cammisa F, Albert T, Boden SD, Hilibrand A, Goldberg H, Berven S, An H; SPORT Investigators. Surgical versus nonsurgical therapy for lumbar spinal stenosis. N Engl J Med. 2008 Feb 21;358(8):794-810. doi: 10.1056/NEJMoa0707136.
PubMed 18287602Kalichman L, Cole R, Kim DH, Li L, Suri P, Guermazi A, Hunter DJ. Spinal stenosis prevalence and association with symptoms: the Framingham Study. Spine J. 2009 Jul;9(7):545-50. doi: 10.1016/j.spinee.2009.03.005. Epub 2009 Apr 23.
PubMed 19398386Deyo RA, Mirza SK, Martin BI. Error in trends, major medical complications, and charges associated with surgery for lumbar spinal stenosis in older adults. JAMA. 2011 Sep 14;306(10):1088. doi: 10.1001/jama.2011.1300. No abstract available.
PubMed 21917578Weinstein JN, Lurie JD, Olson PR, Bronner KK, Fisher ES. United States' trends and regional variations in lumbar spine surgery: 1992-2003. Spine (Phila Pa 1976). 2006 Nov 1;31(23):2707-14. doi: 10.1097/01.brs.0000248132.15231.fe.
PubMed 17077740Atlas SJ, Keller RB, Wu YA, Deyo RA, Singer DE. Long-term outcomes of surgical and nonsurgical management of lumbar spinal stenosis: 8 to 10 year results from the maine lumbar spine study. Spine (Phila Pa 1976). 2005 Apr 15;30(8):936-43. doi: 10.1097/01.brs.0000158953.57966.c0.
PubMed 15834339Delitto A, Piva SR, Moore CG, Welch WC. Surgery Versus Nonsurgical Treatment of Lumbar Spinal Stenosis. Ann Intern Med. 2015 Sep 1;163(5):397-8. doi: 10.7326/L15-5129-4. No abstract available.
PubMed 26322703Patel J, Osburn I, Wanaselja A, Nobles R. Optimal treatment for lumbar spinal stenosis: an update. Curr Opin Anaesthesiol. 2017 Oct;30(5):598-603. doi: 10.1097/ACO.0000000000000495.
PubMed 28696946Bodeker G. Lessons on integration from the developing world's experience. BMJ. 2001 Jan 20;322(7279):164-7. doi: 10.1136/bmj.322.7279.164. No abstract available.
PubMed 11159579Jung B, Bae S, Kim S. Use of Western Medicine and Traditional Korean Medicine for Joint Disorders: A Retrospective Comparative Analysis Based on Korean Nationwide Insurance Data. Evid Based Complement Alternat Med. 2017;2017:2038095. doi: 10.1155/2017/2038095. Epub 2017 Dec 6.
PubMed 29456569Lee YJ, Shin JS, Lee J, Kim MR, Ahn YJ, Shin YS, Park KB, Shin BC, Lee MS, Kim JH, Cho JH, Ha IH. Survey of integrative lumbar spinal stenosis treatment in Korean medicine doctors: preliminary data for clinical practice guidelines. BMC Complement Altern Med. 2017 Aug 29;17(1):425. doi: 10.1186/s12906-017-1942-6.
PubMed 28851418Hadianfard MJ, Aminlari A, Daneshian A, Safarpour AR. Effect of Acupuncture on Pain and Quality of Life in Patients with Lumbar Spinal Stenosis: A Case Series Study. J Acupunct Meridian Stud. 2016 Aug;9(4):178-82. doi: 10.1016/j.jams.2015.11.032. Epub 2015 Nov 17.
PubMed 27555222Kim K, Jeong Y, Youn Y, Choi J, Kim J, Chung W, Kim TH. Nonoperative Korean Medicine Combination Therapy for Lumbar Spinal Stenosis: A Retrospective Case-Series Study. Evid Based Complement Alternat Med. 2015;2015:263898. doi: 10.1155/2015/263898. Epub 2015 Oct 12.
PubMed 26543486Oka H, Matsudaira K, Takano Y, Kasuya D, Niiya M, Tonosu J, Fukushima M, Oshima Y, Fujii T, Tanaka S, Inanami H. A comparative study of three conservative treatments in patients with lumbar spinal stenosis: lumbar spinal stenosis with acupuncture and physical therapy study (LAP study). BMC Complement Altern Med. 2018 Jan 19;18(1):19. doi: 10.1186/s12906-018-2087-y.
PubMed 29351748Qin Z, Ding Y, Xu C, Kwong JSW, Ji Y, Wu A, Wu J, Liu Z. Acupuncture vs Noninsertive Sham Acupuncture in Aging Patients with Degenerative Lumbar Spinal Stenosis: A Randomized Controlled Trial. Am J Med. 2020 Apr;133(4):500-507.e20. doi: 10.1016/j.amjmed.2019.08.038. Epub 2019 Sep 13.
PubMed 31525334Kim KH, Kim YR, Baik SK, Noh SH, Kim DH, Lee SW, Yang GY. Acupuncture for patients with lumbar spinal stenosis: a randomised pilot trial. Acupunct Med. 2016 Aug;34(4):267-74. doi: 10.1136/acupmed-2015-010962. Epub 2016 Mar 7.
PubMed 26953235
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long Term Follow up of Spinal Stenosis Inpatients Treated With Korean Integrative Medicine Treatment.
- ClinicalTrials.gov ID
- NCT04443738
- Acronym / sponsor ID
- JS-CT-2020-06
- Keywords
- acupuncture therapy, herbal medicine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 378 participants (actual)
- Lead sponsor
- Jaseng Medical FoundationUniversity, hospital or other
- Study start
- 12 Jun 2020 (actual)
- Primary completion
- 16 Sep 2020 (actual)
- Study completion
- 16 Sep 2020 (actual)
- First posted
- 23 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to reveal the effectiveness and safety of integrative Korean medicine for spinal stenosis by observation inpatients treated with integrative Korean medicine.
Detailed description
This study is a prospective observational study. The subjects for study are patients diagnosed with spinal stenosis and who have been admitted to four Jaseng Hospital of Korean medicine (Gangnam, Bucheon, Daejeon, and Haeundae) for 2015.01-2018.12.
Medical records of selected patients will be analyzed, and telephone surveys will be conducted for each patient. The survey questions are Numeric rating scale (NRS), Oswestry disability index (ODI), quality of life, and Patient Global Impression of Change (PGIC), etc.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The subjects for study are patients diagnosed with spinal stenosis and who have been admitted to four Jaseng Hospital of Korean medicine (Gangnam, Bucheon, Daejeon, and Haeundae) for 2015.01-2018.12.
Key inclusion criteria (4 listed)
- Patients diagnosed with spinal stenosis by an Korean medicine doctor and was admitted to Jaseng hospital of Korean medicien.
- Patients undergone MRI readings of central spinal stenosis
- Patients have no communication problems
- Patients have agreed to participate the study.
Key exclusion criteria (4 listed)
- Patients who have been diagnosed with certain serious diseases that may cause back pain or neck pain (tumor metastases to the spine, acute fractures, spinal dislocations, and so on)
- Patient hospitalized for pain caused by a traffic accident
- Patients with serious mental illness
- Patients deemed unable to participate in the clinical research by other researchers
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| phone surveyA questionnaire about the current symptoms and satisfaction for recieved treatment will be conducted over the phone for patients. | Other | – |
Primary outcome
Numeric rating scale (NRS)
Time frame: Finish survey by August 2020
NRS uses an 11-point scale to evaluate current neck pain and radiating pain where no pain is indicated by '0', and the worst pain imaginable by '10'. NRS was assessed at admission, 2 weeks after admission, discharge, and long term follow up.
7 secondary outcomes
Oswestry disability index (ODI)
Time frame: Finish survey by August 2020
The five level version of EuroQol-5 Dimension (EQ-5D)
Time frame: Finish survey by August 2020
Patient Global Impression of Change (PGIC)
Time frame: Finish survey by August 2020
Spine surgery
Time frame: Finish survey by August 2020
Current symptoms
Time frame: Finish survey by August 2020
Treatment after discharge
Time frame: Finish survey by August 2020
hanbangchilyo manjogdo 9/5000 Satisfaction with integrative Korean medicine
Time frame: Finish survey by August 2020
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2022.
- Background: PubMed 18287602Weinstein JN, Tosteson TD, Lurie JD, Tosteson AN, Blood E, Hanscom B, Herkowitz H, Cammisa F, Albert T, Boden SD, Hilibrand A, Goldberg H, Berven S, An H; SPORT Investigators. Surgical versus nonsurgical therapy for lumbar spinal stenosis. N Engl J Med. 2008 Feb 21;358(8):794-810. doi: 10.1056/NEJMoa0707136.
- Background: PubMed 19398386Kalichman L, Cole R, Kim DH, Li L, Suri P, Guermazi A, Hunter DJ. Spinal stenosis prevalence and association with symptoms: the Framingham Study. Spine J. 2009 Jul;9(7):545-50. doi: 10.1016/j.spinee.2009.03.005. Epub 2009 Apr 23.
- Background: PubMed 21917578Deyo RA, Mirza SK, Martin BI. Error in trends, major medical complications, and charges associated with surgery for lumbar spinal stenosis in older adults. JAMA. 2011 Sep 14;306(10):1088. doi: 10.1001/jama.2011.1300. No abstract available.
- Background: PubMed 17077740Weinstein JN, Lurie JD, Olson PR, Bronner KK, Fisher ES. United States' trends and regional variations in lumbar spine surgery: 1992-2003. Spine (Phila Pa 1976). 2006 Nov 1;31(23):2707-14. doi: 10.1097/01.brs.0000248132.15231.fe.
- Background: PubMed 15834339Atlas SJ, Keller RB, Wu YA, Deyo RA, Singer DE. Long-term outcomes of surgical and nonsurgical management of lumbar spinal stenosis: 8 to 10 year results from the maine lumbar spine study. Spine (Phila Pa 1976). 2005 Apr 15;30(8):936-43. doi: 10.1097/01.brs.0000158953.57966.c0.
- Background: PubMed 26322703Delitto A, Piva SR, Moore CG, Welch WC. Surgery Versus Nonsurgical Treatment of Lumbar Spinal Stenosis. Ann Intern Med. 2015 Sep 1;163(5):397-8. doi: 10.7326/L15-5129-4. No abstract available.
- Background: PubMed 28696946Patel J, Osburn I, Wanaselja A, Nobles R. Optimal treatment for lumbar spinal stenosis: an update. Curr Opin Anaesthesiol. 2017 Oct;30(5):598-603. doi: 10.1097/ACO.0000000000000495.
- Background: PubMed 11159579Bodeker G. Lessons on integration from the developing world's experience. BMJ. 2001 Jan 20;322(7279):164-7. doi: 10.1136/bmj.322.7279.164. No abstract available.
- Background: PubMed 29456569Jung B, Bae S, Kim S. Use of Western Medicine and Traditional Korean Medicine for Joint Disorders: A Retrospective Comparative Analysis Based on Korean Nationwide Insurance Data. Evid Based Complement Alternat Med. 2017;2017:2038095. doi: 10.1155/2017/2038095. Epub 2017 Dec 6.
- Background: PubMed 28851418Lee YJ, Shin JS, Lee J, Kim MR, Ahn YJ, Shin YS, Park KB, Shin BC, Lee MS, Kim JH, Cho JH, Ha IH. Survey of integrative lumbar spinal stenosis treatment in Korean medicine doctors: preliminary data for clinical practice guidelines. BMC Complement Altern Med. 2017 Aug 29;17(1):425. doi: 10.1186/s12906-017-1942-6.
- Background: PubMed 27555222Hadianfard MJ, Aminlari A, Daneshian A, Safarpour AR. Effect of Acupuncture on Pain and Quality of Life in Patients with Lumbar Spinal Stenosis: A Case Series Study. J Acupunct Meridian Stud. 2016 Aug;9(4):178-82. doi: 10.1016/j.jams.2015.11.032. Epub 2015 Nov 17.
- Background: PubMed 26543486Kim K, Jeong Y, Youn Y, Choi J, Kim J, Chung W, Kim TH. Nonoperative Korean Medicine Combination Therapy for Lumbar Spinal Stenosis: A Retrospective Case-Series Study. Evid Based Complement Alternat Med. 2015;2015:263898. doi: 10.1155/2015/263898. Epub 2015 Oct 12.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
In-Hyuk Ha, Dr. study director
Jaseng Medical Foundation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spinal Stenosis Lumbar and Medicine, Korean Traditional, run by Jaseng Medical Foundation at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numeric rating scale (NRS) (time frame: Finish survey by August 2020). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04443738, which also lists 20 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2022.